Cleared Traditional

K941585 - HYGROSTER

K941585 is an FDA 510(k) clearance for HYGROSTER, manufactured by Mallinckrodt Medical. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K941585 · Mallinckrodt Medical · Anesthesiology device
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Apr 1994
Decision
19d
Days
Class 1
Risk

K941585 is an FDA 510(k) clearance for the HYGROSTER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Mallinckrodt Medical (Argyle, US). The FDA issued a Cleared decision on April 19, 1994 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallinckrodt Medical devices

FDA 510(k) Submission Details - K941585

510(k) Number K941585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date April 19, 1994
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

All 33
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K941585.
HYGROLIFE
K942794 · Mallinckrodt Medical · Aug 1994
HEAT AND MOISTURE EXCHANGERS AND FILTERS
K941987 · Icor AB · Aug 1994
AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF
K941436 · Icor AB · Jun 1994
TRACHEOLIFE
K941535 · Mallinckrodt Medical · Apr 1994
HEPA FILTERED HEAT AND MOISTURE EXCHANGER
K935036 · Intertech Resources, Inc. · Jan 1994
KING SYSTEMS HME
K934441 · King Systems Corp. · Dec 1993